The present invention relates to a cancellous bone graft substitute and a method of manufacturing the same, and more particularly, to a cancellous bone graft substitute and a method of manufacturing the same by which defatting, demineralizing, cleaning, and sterilizing processes are performed within a short time using a supersonic cavitation without damaging a surface and an inside of a bone tissue so as to further rapidly, effectively supply an allogeneic or xenogeneic bone graft substitute, internal and external concentrations of Ca++ of the allogeneic or xenogeneic bone graft substitute are effectively removed so as to maintain physical properties of the allogeneic or xenogeneic bone graft substitute, such as an elastic intensity and the like, osteogenesis induction factors of a demineralized bone matrix (DBM), such as bone morphogenetic proteins (BMPs), growth factors, and proteoglycan, are protected so as to effectively grow the osteoinductive factors, and a protectant is applied to the allogeneic or xenogeneic bone graft substitute so as not to easily dissolve or inactivate the allogeneic or xenogeneic hone graft substitute.
Bone grafts are applied to fill spaces of bone tissues, which are damaged by bone diseases such as bone troubles, bone tumors, and the like, with bone graft substitutes or to induce bone joints, bone integrations, and joint fixations. The development and necessity of industrialization and medical science have been expanded with an increase in an aged population and the qualitative improvement of lives. Thus, researches on simpler, more effective bone cure graft substitutes have been actively conducted in order to cope with the development and necessity of industrialization and medical science.
The most generally used bone graft method is a self-graft method of extracting a part of a bone of a graftee in order to implant the extracted part to a damaged part of the bone. If an autogenous cancellous bone (ACB) is implanted to a damaged part as described above, alive cells related to a bone matrix and osteogenesis are supplied to a graft part. Thus, the ACB more rapidly generate a bone than other graft substitutes, hardly causes an immune rejection response, and does not cause osteoclasis so as to improve osteoconductive and osteoinductive capabilities.
However, since a graft substitute is extracted from a graftee in the above-described self-graft method, a surgical operation must be performed with respect to a damaged part of a bond and a part from which the graft substitute has been extracted. Also, an amount of the graft substitute obtained from the graftee is very limited.
Therefore, an allograft using a bone of another person not a graftee or a xenograft (Mulliken et al., Calcif. Tissue Int. 33:71, 1981; Neigel et al., Opthal. Plast. Teconstr. Surg. 12:108, 1996; Whiteman et al., J. Hand. Surg. 18B: 487, 1993; Xiaobo et al., Clin. Orthop. 293:360, 1993) using a bone of an animal has been developed in order to solve the above-mentioned problems of the self-graft method. With the development of the allograft and the xenograft, an allogeneic or xenogeneic demineralized bone matrix (DBM) has been developed in order to remove cells, blood, a lipid layer, and the like, which causes an immune rejection response, from a graft substitute and activate osteoinductive BMPs which participate in osteoinduction.
The allogeneic or xenogeneic demineralized DBM does not require a secondary operation for extracting a graft substitute, is demineralized (i.e., is easily processed) to be appropriate for characteristics of a graftee, and smoothly supply a graft substitute. In order to manufacture such a DBM, an allogeneic or xenogeneic bone is cleaned, defatted, antisepticized, and/or sterilized in order to remove infectious viruses, is cut using micromachining, and is soaked in an acid solution.
However, a well-known method of manufacturing an allogeneic or xenogeneic DBM requires a considerable amount of time in order to manufacture the allogeneic or xenogeneic DBM. Also, since graft substitutes, which are manufactured and commercialized by the well-known method, are rapidly dissolved after being implanted, they considerably reduce an osteoinductive activation within 24 hours after the implantation. Also, some of the graft substitutes are inactivated within 6 hours after the implantation and thus lose their osteoconductive and osteoinductive capabilities.
This is because general vacuum freeze drying is performed in order to supply bone graft substitutes at appropriate times. Since the vacuum freeze drying repeats freezing and dehydrating, biomechanical characteristics of a bone tissue are deteriorated, which damages the bone graft substitutes. Also, when gamma radioactive rays are irradiated as an alternative to the vacuum freeze drying or the vacuum freeze drying and the irradiation of gamma radioactive rays are simultaneously used, the damages to the bone graft substitutes are amplified.
Accordingly, with the increases in usage of bone graft substitutes, there is required to be developed a method of further simply, rapidly supplying a high-quality allogeneic or xenogeneic cure bone graft substitute and effectively complementing a damage to the bone graft substitute which is caused during the manufacture of the bone graft substitute.